Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-27 @ 3:00 AM
Study NCT ID:
NCT05589493
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-10-21
First Post:
2022-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hybrid PEEK-Acrylic Resin Prostheses and the All-on-4 Concept for Full-Arch Rehabilitation - Routine Group
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011475', 'term': 'Prosthesis Failure'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective cohort study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-11-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-18', 'studyFirstSubmitDate': '2022-10-18', 'studyFirstSubmitQcDate': '2022-10-18', 'lastUpdatePostDateStruct': {'date': '2022-10-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival of the prosthesis', 'timeFrame': '5 years', 'description': 'Evaluation of the survival for the PEEK-acrylic resin implant-supported prosthesis; nominal (survival,failure)'}], 'secondaryOutcomes': [{'measure': 'Survival of the implants', 'timeFrame': '5 years', 'description': 'Evaluation of the survival for implants supporting the PEEK-acrylic resin implant-supported prosthesis; nominal (survival,failure)'}, {'measure': 'Incidence of biological complications', 'timeFrame': '5 years', 'description': 'Peri-implant infection, abscess, fistulae, suppuration, sinus infection, gingival dehiscence; Nominal (no incidence, incidence)'}, {'measure': 'Incidence of mechanical complications', 'timeFrame': '5 years', 'description': 'Loosening or fracture of prosthetic components; Nominal (no incidence, incidence)'}, {'measure': 'Marginal bone resorption', 'timeFrame': '5 years', 'description': 'Measured through periapical radiographs, in mm between the implant shoulder and the most apical portion of implant-bone contact; Scale'}, {'measure': 'Denture staining', 'timeFrame': '5 years', 'description': 'Veneer discoloration or staining. If JUVORA is exposed same discoloration or staining 0:heavily stained; 10: no stains'}, {'measure': 'In mouth comfort', 'timeFrame': '5 years', 'description': 'Visual analogue scale (0-10 cm); 0:very poor; 10: very good'}, {'measure': 'Overall chewing feeling', 'timeFrame': '5 years', 'description': 'Visual analogue scale (0-10 cm); 0:very poor; 10: very good'}, {'measure': 'Oral Health Impact Profile OHIP-14', 'timeFrame': '5 years', 'description': 'Likert Scale (0=least impact/never, 4=highest impact/very often)'}, {'measure': 'Patient tissue reaction', 'timeFrame': '5 years', 'description': 'Visual analogue scale (0-10 cm); 0:very poor; 10: very good'}, {'measure': 'Framework integrity', 'timeFrame': '5 years', 'description': 'Visual analogue scale (0-10 cm); 0:very poor; 10: very good'}, {'measure': 'Veneer adhesion', 'timeFrame': '5 years', 'description': 'Visual analogue scale (0-10 cm); 0:very poor; 10: very good'}, {'measure': 'Manufacture issues', 'timeFrame': '5 years', 'description': 'Visual analogue scale (0-10 cm); 0:very poor; 10: very good'}, {'measure': 'Handling of material compared to metal', 'timeFrame': '5 years', 'description': 'Visual analogue scale (0-10 cm); 0:very poor; 10: very good'}, {'measure': 'Aesthetics', 'timeFrame': '5 years', 'description': 'Visual analogue scale (0-10 cm); 0:very poor; 10: very good'}, {'measure': 'Speech', 'timeFrame': '5 years', 'description': 'Visual analogue scale (0-10 cm); 0:very poor; 10: very good'}, {'measure': 'Fit', 'timeFrame': '5 years', 'description': 'Visual analogue scale (0-10 cm); 0:very poor; 10: very good'}, {'measure': 'Hygiene around the implants', 'timeFrame': '5 years', 'description': 'Visual analogue scale (0-10 cm); 0:very poor; 10: very good'}, {'measure': 'Hygiene - how much plaque/calculus adheres to the prosthesis', 'timeFrame': '5 years', 'description': 'Visual analogue scale (0-10 cm); 0:very poor; 10: very good'}, {'measure': 'Overall classification from KOL', 'timeFrame': '5 years', 'description': 'Visual analogue scale (0-10 cm); 0:very poor; 10: very good'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prosthesis', 'PEEK', 'All-on-4', 'All-on-four', 'dental implants'], 'conditions': ['Prosthesis Survival']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to evaluate the outcome of a Poly-ether-ether-ketone - acrylic resin prosthesis for full-arch rehabilitation of the atrophic maxillae through the All-on-4 concept after five years of follow-up. The main question it aims to answer is:\n\n\\- What is the survival outcome of the full-arch implant-supported Poly-ether-ether-ketone - acrylic resin prosthesis? The participants already rehabilitated with dental implants will receive a Poly-ether-ehter-ketone prosthesis as a definitive prosthesis.', 'detailedDescription': 'Following the learning generated during a development study with implant supported fixed prostheses using polyetheretherketone (PEEK) material, it is necessary to evaluate the outcome of implant supported fixed prosthetic rehabilitations using PEEK material in a routine scenario, following optimized laboratory and treatment protocol.\n\nThe study design will be a prospective single cohort to evaluate the long term outcome of fixed prosthetic implant supported rehabilitations. The cohort will be evaluated at 6 months, 12 months and annually thereafter until 5 years of follow-up. At each follow-up assessments multiple evaluaitons will be performed to assess the overall outcome of the restorations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients rehabilitated with immediate function implants for complete edentulous arches through the All-on-4 Concept.\n* Patients in need of definitive implant-supported restorations.\n* Written informed consent from each patient to participate in the study.\n\nExclusion Criteria:\n\n\\- Hindrance to provide written informed consent. (A patient cannot participate if no written consent is given)'}, 'identificationModule': {'nctId': 'NCT05589493', 'acronym': 'AO4PEEKRG', 'briefTitle': 'Hybrid PEEK-Acrylic Resin Prostheses and the All-on-4 Concept for Full-Arch Rehabilitation - Routine Group', 'organization': {'class': 'OTHER', 'fullName': 'Malo Clinic'}, 'officialTitle': 'Hybrid Polyetheretherketone (PEEK)-Acrylic Resin Prostheses and the All-on-4 Concept for Full-Arch Rehabilitation - Routine Group', 'orgStudyIdInfo': {'id': 'AO4PEEKRoutGroup'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'All-on-4 PEEK routine', 'description': 'Prosthetic full-arch rehabilitation using a PEEK-acrylic resin prosthesis', 'interventionNames': ['Device: Prosthetic full-arch rehabilitation using a PEEK-acrylic resin prosthesis']}], 'interventions': [{'name': 'Prosthetic full-arch rehabilitation using a PEEK-acrylic resin prosthesis', 'type': 'DEVICE', 'otherNames': ['PEEK prosthesis'], 'description': 'A prosthetic full-arch rehabilitation of atrophic maxillae using a PEEk-acrylic resin prosthesis supported by dental implants following the All-on-4 Concept arrangement.', 'armGroupLabels': ['All-on-4 PEEK routine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1600-042', 'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Malo Clinic', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}], 'overallOfficials': [{'name': 'Miguel A de Araújo Nobre, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Director of Research, Development and Education'}]}, 'ipdSharingStatementModule': {'infoTypes': ['SAP'], 'timeFrame': 'Upon study completion and for 8 years.', 'ipdSharing': 'YES', 'description': 'Anonymized database containing the study variables', 'accessCriteria': 'Upon solicitation to the Investigators'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Malo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Invibio Ltd', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}